An AI-Based CDSS for Integrated Management of Patients With Acute Ischemic Stroke(GOLDEN BRIDGE II)

Stroke Clinical Trial

Official title:

A Multi-centre, Cluster Randomized Controlled Trial of an Artificial Intelligence-Based Clinical Decision Support System for Integrated Management of Patients With Acute Ischemic Stroke: The GOLDEN BRIDGE II Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04524624
• Other study ID #: KY 2020-016-02
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: June 30, 2023

Study information

• Verified date: August 2020
• Source: Beijing Tiantan Hospital
• Contact: Zixiao Li, MD
• Phone: 00861013683234256
• Email: lizixiao2008[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will conduct a cluster randomized controlled trial to evaluate the impact of an artificial intelligence-based clinical decision support system for the integrated management of patients with acute ischemic stroke on the adherence to guideline-based therapies and the incidence of new clinical vascular events.

Description:

Artificial intelligence (AI) and clinical decision support system (CDSS) have demonstrated great progress in the diagnosis and treatment of cerebrovascular diseases.CDSS can use computer technology to simulate and extend expert knowledge and empirical evidence in a timely and efficient manner. The combination of AI and CDSS is a potential solution to the shortage of medical resources and can improve the quality of and promote the standardization of medical services. At intervention sites, neurologists will receive support on use of the AI-based CDSS.

Aim: To evaluate the effectiveness of an AI-based CDSS for stroke management in patients with acute ischemic stroke within 7 days of symptom onset.

Intervention: An AI-based CDSS for an integrated management of patients with acute ischemic stroke. The strategy includes automatically identifying acute stroke lesions and lesion patterns, automated classification of stroke subtypes and mechanisms, evidence-based alerts, and guideline-recommended secondary stroke prevention strategies.

Eighty eligible hospitals in china, stratified by hospital capacity (secondary grade or tertiary) and economic-geographical regions (eastern, central, and western), will be randomized into either the CDSS group or the usual care group.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 21689
• Est. completion date: June 30, 2023
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Cluster Inclusion Criteria:

• Secondary or tertiary hospitals with an emergency department and neurologic wards that receive patients with AIS.

• Hospitals with available brain MRI scans (1.5T or 3.0T).

• Patient Inclusion Criteria:

• Patients of 18 years or older.

• Patients admitted with neurological deficit consistent with ischemic stroke within 7 days of of symptoms onset. (*Symptom onset is defined by the "last seen normal" principle)

• Confirmation of new ischemic stroke by objective modality of CT scan and MRI (had relevant lesions on DWI).

• Informed consent from patient or legally authorised representative (primarily spouse, parents, adult children, otherwise indicated).

Exclusion Criteria:

• Cluster Exclusion Criteria:

• Grade-one hospitals and rural hospitals.

• The specialized hospitals, such as women and children specialist hospital and tumor hospital.

• Hospitals with less than 20 patients with suspected AIS per month.

• Patient Exclusion Criteria:

• Diagnosed DWI negative stroke.

• Diagnosed other types of cerebrovascular diseases, such as transient ischaemic attack, hemorrhagic stroke, cerebral venous sinus thrombosis, and so on.

• Diagnosed non cerebral vascular disease, such as stroke mimic, seizures, central nervous system infections, metabolic encephalopathy, and so on.

• Received carotid endarterectomy (CEA) and carotid angioplasty and stenting (CAS).

• Involving in other investigational drug or device clinical trials.

• Patients with malignant disease and life expectancy of less than 3 months or patients who are unable to complete the study for other reasons.

• Women who are pregnant or postpartum (=6 weeks).

• Patients refuse to participate in this study.

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• AI-based CDSS
Automatically identifying acute ischemic stroke lesions on DWI. Classification of stroke subtypes and mechanisms. Evidence-based alerts and guidelines for early stroke management. Guideline-recommended secondary stroke prevention strategies.

Locations

Country	Name	City	State
China	Beijing Tian tan Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

Wang Y, Li Z, Zhao X, Wang C, Wang X, Wang D, Liang L, Liu L, Wang C, Li H, Shen H, Bettger J, Pan Y, Jiang Y, Yang X, Zhang C, Han X, Meng X, Yang X, Kang H, Yuan W, Fonarow GC, Peterson ED, Schwamm LH, Xian Y, Wang Y; GOLDEN BRIDGE-AIS Investigators. Effect of a Multifaceted Quality Improvement Intervention on Hospital Personnel Adherence to Performance Measures in Patients With Acute Ischemic Stroke in China: A Randomized Clinical Trial. JAMA. 2018 Jul 17;320(3):245-254. doi: 10.1001/jama.2018.8802. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Moderate and severe bleeding events according to the GUSTO criteria	Severe bleeding incidence (GUSTO definition), including fatal bleeding and symptomatic intracranial hemorrhage.	3, 6, 12 months
Other	All bleeding events	All bleeding events (severe/moderate bleeding and intracranial hemorrhage)	3, 6, 12 months
Other	Intracranial hemorrhagic events	Intracranial hemorrhagic events	3, 6, 12 months
Other	Total costs of care	Total costs of care	Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Other	Average length of stay	Average length of stay	Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Other	Home time	We calculated home time as total days alive and not in a hospital or skilled nursing facility.	3, 6, 12 months
Other	All-cause readmission	All-cause readmission	3, 6, 12 months
Other	Ischemic stroke readmission	Ischemic stroke readmission	3, 6, 12 months
Other	Hemorrhagic stroke readmission	Hemorrhagic stroke readmission	3, 6, 12 months
Other	Cardiovascular readmission	Cardiovascular readmission	3, 6, 12 months
Other	Adverse events	Adverse events	3, 6, 12 months
Other	Stratified analysis	Efficacy endpoint will also be analyzed stratified by Hospital level(secondary hospitals/tertiary hospitals), economic-geographical regions (eastern, central, and western), stroke severity (NIHSS=3/NIHSS>3) and stroke subtypes.	3, 6, 12 months
Primary	Incidence rate of new clinical vascular events (ischemic stroke, hemorrhagic stroke, myocardial infarction, or vascular death)	To evaluate the efficacy of AI-based CDSS in reducing the risk of new clinical vascular events (ischemic stroke, hemorrhagic stroke, myocardial infarction, or vascular death) at 3 months after initial symptom onset.	3 months
Secondary	Incidence rate of new clinical vascular events (ischemic stroke, hemorrhagic stroke, myocardial infarction, or vascular death)	Incidence rate of new clinical vascular events (ischemic stroke, hemorrhagic stroke, myocardial infarction, or vascular death) at discharge, 6,12-months after initial symptom onset.	6, 12 months
Secondary	Disability	Degree of disability (measured by the Modified Rankin Scale) at discharge, 3, 6, and 12 months	3, 6, 12 months
Secondary	All-or-none measure of evidence-based performance measures	Proportion of prescription of evidence-based performance measures. "All or none" measures including the evidence-based therapies: antithrombotic medication within 48 hours after symptom onset, dual antiplatelet therapy (aspirin and clopidogrel) started within 24 hours after symptom onset (NIHSS score =3), intensive statin therapy, antihypertensive, hypoglycemic medications, dysphagia screening, and deep vein thrombosis prophylaxis within 48 hours of admission. Discharge therapies include: antithrombotics, lipid lowering agents, anticoagulants for atrial fibrilation or flutter, antihypertensive, and hypoglycemic medications.	Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Secondary	A composite measure score of performance measures	The composite measure score was defined as the total number of eligible performance measures performed divided by the total number of performance measures for which a given patient was eligible.	Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Secondary	All-cause mortality	All-cause mortality	3, 6, 12 months